Request#20.051Topic/Issue: Request to establish a new Level II HCPCS code to identify an amniotic matrix-derived human cell and tissue product. Trade name: AmnioCyte PlusApplicant’s suggested language: Q4XXX AmnioCyte Plus, per 0.5 mLApplicant’s SummaryPredictive Biotech kindly requests to establish a new Level II HCPCS code to identify an amniotic matrix derived human cell and tissue product AmnioCyte Plus. AmnioCyte Plus is a minimally manipulated human tissue allograft derived from the extracellular matrix of the amniotic membrane. It is processed to preserve the cytokines, growth factors and scaffolding proteins from within the amniotic membrane matrix for homologous use. AmnioCyte Plus is intended for use in repair, reconstruction, replacement or supplementation of a recipient's cells or tissue by performing the same basic functions of amniotic membrane matrix in the recipient as it would in the donor. The amount and administration (injected or topical) of the allograft is determined by the clinician based on the intended use in each patient. The product is distributed as a liquid allograft contained in a vial that is shipped frozen for preservation (-80C on dry ice) and is intended to be stored in that frozen state (-60C to -80C or colder) until used or expiration date is reached. It can be ordered in 3 vial sizes: 0.5 mL, 1 mL or 2 mL. The product is simply drawn up after proper thawing using a 21G-23G needle to syringe and then prepared and applied. According to the applicant, existing categories for products similar to AmnioCyte Plus are inadequate due to variances in the way these products are received, processed and preserved, therefore, each product yields a potentially different consistency and activity of active components that may or may not best represent the donor source. As per the applicant, the payers are carefully reviewing each product and being highly selective of those that they are willing to cover as medically necessary. CMS Decision.Establish a new Level II HCPCS code Q4242 "Amniocyte plus, per 0.5 cc." Effective: 07/01/2020
